Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).

This is a multicenter, randomized, comparative, patient-blinded study. Patients with NHL, HD or MM who would benefit from an autologous stem cell transplant, who failed previous collections or collection attempts with a mobilization regimen of chemotherapy with or wihoutG-CSF, and who meet the inclusion/exclusion criteria are eligible to receive AMD3100(240µg/kg) or placebo (both given as an evening dose). Patients will undergo mobilization with G-CSF (10µg/kg) for 4 consecutive days. On Day 4, AMD3100 (240µg/kg) or placebo will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on each day of apheresis. G-CSF will be administered in the morning and approximately 1 hour prior to apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses until a minimum of 2x10\^6 CD34+ cells/kg or greater than or equal to 5x10\^6 CD34+cells/kg are collected. More cells may be collected, if done within the 7 aphereses. Patients who are to receive a tandem transplant will undergo a minimum of 2 and maximum of 7 aphereses until a minimum of 4x10\^6 CD34+ cells/kg are collected. Aphereses should be performed on consecutive days (including weekend days) The patient will have a peripheral blood (PB) sample collected to measure the number of CD34+ cell in PB at baseline prior to administration of G-CSF, prior to each administration of AMD3100 or placebo and at the initiation of apheresis. In addition, a sample will be obtained from each apheresis product to measure the number of CD34+ cells collected in the apheresis product. Patients who fail to collect greater than or equal to 0.8x10\^6 CD34+ cells/kg in 7 aphereses will be offered a rescue arm giving AMD3100 plus G-CSF. Patients will undergo their ablative chemotherapy before transplantation. Patients will then be transplanted. The success of the transplantation will be evaluated. Graft durability will be evaluated to 12 months post-transplant. In the event that a sufficient number of cells for transplantation are not obtained from the collections, cells may be retained, pooled, and transplanted at a later date at the Investigator's discretion.